Benfit of Remote Monitoring in Pacemaker

Condition(s) studied

Investigational drug(s) / intervention(s)

Remote Monitoring arm: Patients will be follow-up using remote monitoring. In the RM follow-up arm, the patients are not mandated to visit the clinic unless there is unscheduled call due to adverse event notification.

Study summary

Modern CIEDs are equipped with remote monitoring (RM) technology, which provides automatic transmissions of diagnostics and technical data from the implanted devices to the attending physician. RM has been shown to be a safe alternative to the conventional in-hospital visits, especially for low-risk patients, such as pacemaker recipients. These regular office visits include examinations of device function and patient clinical status, and may prompt the reprogramming of the device or changes in medication regimens. The efficiency of this strategy is, however, questionable since, in the majority of scheduled visits, the device programming or drug regimen is left unchanged. To optimize the follow-up of device recipients, systems have been developed, which allow the automatic teletransmission of data stored in the devices' memories, including battery voltage, lead characteristics, and arrhythmias. The data sent by a home transmitter allow the remote surveillance of patients and eliminate unnecessary ambulatory visits. Clinical studies of these new systems have been conducted mostly in recipients of cardioverter defibrillators, and only a few studies of permanently paced patients have been published.

However, due to the absence of medical regulations and systems for remote monitoring in Korea, the government does not provide clear guidelines and the Korean HIRA (Health Insurance Review \& Assessment Service) is yet to set any reimbursement standards for home-transmitter and remote monitoring. As a result, most Korean physicians cannot practically use remote monitoring for CIED patients. Therefore, this project shall contribute to address the benefits of remote monitoring to the government and expediate the system to be set in the country.

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia in the general population. AF has enormous socioeconomic implications because it increases the risk of mortality and morbidity resulting from stroke, congestive heart failure, dementia and impaired quality of life. To prevent the AF-related complication, early detection of AF is very important. Despite the latest HRS Expert Consensus Statement which has set a class I recommendation for RM as useful tool for the early detection and quantification of AF, there are still few data on the clinical reactions triggered by the AHRE detected by RM of CIEDs and on their possible benefit on patient's outcome.

The incidence of atrial high rate episodes (AHRE)/subclinical AF in patients with a pacemaker/implanted device is 30-70%, but it may be lower in the general population. Longer episodes of AHRE/subclinical AF (minimum of 5-6 min) are associated with an increased risk of clinical AF, ischemic stroke, major adverse cardiovascular events, and cardiovascular death.13 Clinical AF will reportedly develop in 1 in 5-6 of patients within 2.5 years after diagnosing AHRE/subclinical AF.

The remote monitoring feature is available in all geographies while it is yet to be reimbursed in South Korea. To be reimbursed by the NHIS of Korea, the data supporting the benefit of RM is necessary. By comparing clinical and economic benefits of remote monitoring, we might be able to set a guideline on the usage of remote monitoring in pacemaker patients.

Eligibility

Primary outcome measure(s)

• major adverse event (MAE) — Arm 1: 6 month, 12 month, 18 month, 24 month, anytime using remote monitoring - Arm 2: 6 month, 12 month, 18 month, 24 month
  major adverse event (MAE), including all-cause death and hospitalizations for device-related or cardiovascular adverse events

Trial sites (1)

More Yonsei University trials in South Korea